BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC PARASITE PANEL

    MDR report key: 22951755 · Received September 3, 2025

    Report

    Report Number
    3007420875-2025-00149
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    July 29, 2024
    Report Date
    June 10, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904429607
    PMA / PMN Number
    K220193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPE: PCH: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX ENTERIC PARASITE PANEL KIT (REF. 442960) LOTS 3200365, 3265834 AND 4017468 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED UNUSUAL CURVES ASSOCIATED WITH POSITIVE GIARDIA (GLAMB) AND CRYPTOSPORIDIUM (CRYPTO) TARGETS THAT REPEATED NEGATIVE WHEN USING BD MAX¿ ENTERIC PARASITE PANEL KIT LOTS 3200365, 3265834 AND 4017468. REVIEW OF MANUFACTURING RECORDS OF THE BD MAX ENTERIC PARASITE PANEL INDICATED THAT THE LOTS 3200365, 3265834 AND 4017468 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUNS 2888, 2891, 2980 AND 3188 FROM INSTRUMENT CT1566 FOR INVESTIGATION. SAMPLES TESTED WITH ENTERIC PARASITE PANEL KIT LOT 3200365 (RUN 2888; POSITION B6 AND 2891; B11), KIT LOT 3265834 (RUN 2980; POSITIONS B2 AND B4) AND KIT LOT 4017468 (RUN 3188; POSITION B2) WERE TARGETED AS TO BE INVESTIGATED BY THE CUSTOMER. SAMPLES IN RUN 2888; POSITION B6, 2891; B11 AND 2980; B4 TESTED POSITIVE FOR THE GLAMB TARGET, SAMPLE IN RUN 3188; POSITION B2 TESTED POSITIVE FOR THE CRYPTO TARGET, AND SAMPLE IN RUN 2980; POSITION B2 TESTED POSITIVE FOR BOTH GLAMB AND CRYPTO TARGETS. ALL TESTED NEGATIVE UPON REPEAT. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE POSITIVE SAMPLES TARGETED. ANALYSIS REVEALED STEP DISLOCATIONS IN THE RAW PCR SIGNAL IN EVERY CHANNEL, RESULTING IN POSITIVE RESULTS FOR FOUR OF THE SAMPLES (RUNS 2891; POSITION B11, 2888; B6, 2980; B2 AND 3188; B2). IT IS UNLIKELY THESE POSITIVE RESULTS WITH ATYPICAL CURVES ARE TRUE AMPLIFICATIONS. SAMPLE IN RUN 2980; POSITION B4 SHOWED CURVES THAT SUGGEST A TRUE POSITIVE RESULT. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE ISSUES REPORTED OCCURRED OVER A PERIOD OF SIX MONTHS, USING THREE DIFFERENT KIT LOTS, SUGGESTING THAT THE ISSUE IS NOT LINKED TO SPECIFIC REAGENTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX ENTERIC PARASITE PANEL LOTS 3200365, 3265834 OR 4017468. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND A PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD MAX¿ ENTERIC PARASITE PANEL, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386459 BD MAX¿ ENTERIC PARASITE PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 3265834 00382904429607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown